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Not yet recruiting NCT07411768

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

No phase Interventional Transcatheter Aortic Valve Replacement Transcatheter Heart Valve Thrombosis Anti-inflammatory Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colchicine, Standard Care.
Who it may be relevant to
Registry conditions: Transcatheter Aortic Valve Replacement, Transcatheter Heart Valve Thrombosis, Anti-inflammatory Therapy. Basic parameters: 60 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial of Anti-Inflammatory Therapy to Reduce Transcatheter Heart Valve Thrombosis After Transfemoral Transcatheter Aortic Valve Replacement

Overview

This prospective, randomized, open-label study aims to evaluate the efficacy and safety of low-dose colchicine (0.5 mg daily) in reducing transcatheter heart valve (THV) thrombosis in patients after TAVR. Participants will be randomly assigned to either receive colchicine plus standard care or standard care alone for 12 months. The primary goal is to compare the rate of valve thrombosis between the two groups using 4D-CT imaging at one year. Additionally, the study will evaluate the treatment's impact on clinical outcomes and its overall safety profile.

Detailed description

To ensure balance between the two groups of patients in key prognostic factors, stratified randomization will be used. Stratification factors include: (1) type of implanted prosthetic valve (bulbar valve/self-expanding valve); (2) postoperative baseline antithrombotic regimen (antiplatelet therapy/anticoagulation therapy). Within each stratum, block randomization will be performed using a computer-generated random sequence.

Interventions

  • Drug Colchicine
    Colchicine 0.5 mg orally once daily for 12 months
  • Other Standard Care
    Standard pharmacological management and long-term postoperative care according to current clinical guidelines and expert consensus for TAVR patients

Primary outcome measures

  • Incidence of Transcatheter Heart Valve (THV) Thrombosis [Time frame: 1 year]
Secondary outcome measures (3)
  • Clinical Composite Endpoint: Including stroke, rehospitalization for heart failure, valve dysfunction, and all-cause mortality [Time frame: 1 month, 1 year]
  • Dynamic Changes in Inflammatory/Coagulation Biomarkers [Time frame: 1 month, 1 year]
  • Safety Evaluation: Incidence of adverse drug reactions and laboratory abnormalities [Time frame: 1 month, 1 year]

Eligibility criteria

Inclusion criteria

  • Patients with aortic stenosis aged 60-85 years.
  • Successful transfemoral TAVR (per VARC-3 criteria).
  • Voluntary participation with signed Informed Consent Form.

Exclusion criteria

  • Known hypersensitivity, allergy, or documented intolerance to colchicine.
  • Hematologic abnormalities defined as hemoglobin <80 g/L or white blood cell count <4.0 × 10⁹/L at screening.
  • Severe renal impairment defined as creatinine clearance <30 mL/min (calculated by the Cockcroft-Gault formula) or serum creatinine >2 × upper limit of normal (ULN).
  • Significant hepatic disease, including liver cirrhosis, chronic active hepatitis, hepatic injury (alanine aminotransferase >3 × ULN or total bilirubin >2 × ULN), or cholestasis.
  • Known history of bone marrow suppression.
  • Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inhibitors, including but not limited to cyclosporine, amiodarone, clarithromycin, erythromycin, omeprazole, or verapamil.
  • Concomitant use of strong CYP3A4 or P-glycoprotein (P-gp) inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, or rifampin.
  • Known neuromuscular disorders or creatine kinase (CK) >3 × ULN at screening.
  • Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea.
  • Active malignancy or history of cancer.
  • Current use of systemic corticosteroids (oral or intravenous) or systemic immunosuppressive agents (topical or inhaled corticosteroids permitted).
  • Acute inflammatory condition or active viral infection at the time of enrollment.
  • Known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Estimated life expectancy <1 year as determined by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sc — Beijing

Identifiers

NCT: NCT07411768 · 2025-I2M-C&T-B-026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗